Effectiveness of in-group versus individually administered pain neuroscience education on clinical and psychosocial outcomes in patients with chronic low back pain: randomized controlled study protocol

Objective (1) This trial will compare the clinical and psychosocial effectiveness of in-group and individually pain neuroscience education (PNE) in patients with chronic low back pain (CLBP). In addition, (2) the influence of social determinants of health on post-treatment results will be analyzed. Methods A three-arm randomized controlled trial will be conducted. Sixty-nine participants with CLBP will be recruited in a 1:1:1 ratio. Participants, assessor, and statistician will be blinded to group assignment. The PNE intervention will be adapted to the context of the participants. An experimental group (n = 33) will receive PNE in an in-group modality, the other experimental group (n = 33) will receive PNE in an individually modality and the control group (n = 33) will continue with usual care. Additionally, participants will be encouraged to stay active by walking for 20–30 min 3–5 times per week and will be taught an exercise to improve transversus abdominis activation (bracing or abdominal following). The outcome measures will be fear avoidance and beliefs, pressure pain threshold, pain self-efficacy, catastrophizing, pain intensity, and treatment expectation. Outcome measures will be collected at one-week before intervention, immediately post-intervention, and four-weeks post-intervention. Conclusion The innovative approach of PNE oriented to fear beliefs proposed in this study could broaden the application strategies of this educational therapeutic modality. Impact. Contextualized PNE delivered by physical therapist could be essential to achieve a good cost-effectiveness ratio of this intervention to improve the clinical condition of people with CLBP.


Study Description
Brief Summary: An educational intervention on the neurophysiology of chronic pain will be provided.The content of the intervention will be identical in the experimental groups (group and individual).The intervention has an active educational approach based on reconceptualizing the maladaptive beliefs that influence the fear-avoidance behavior of the participants through updated contents of the neuroscience of pain.
The effects of the intervention will be compared between the groups and the influence of the social determinants of health on the effects will also be determined.
The investigators hypothesize that there will be significant differences in favor of the group intervention group over the individual intervention groups.Furthermore, the effects will be influenced by the social determinants of health in both experimental groups.
Detailed Description:

Arms Assigned Interventions Experimental: Group Pain Neuroscience Education
A single face-to-face group session of approximately 60-80 minutes provided through active participation.
Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation.In addition, participants will be Pain neuroscience Education A pain neuroscience education session geared towards fear-avoidance beliefs

Arms
Assigned Interventions encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through).
With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain).Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person.This activity must be delivered in the second evaluation.

Experimental: Individual Pain Neuroscience Education
A single one-on-one face-to-face session of approximately 60-80 minutes provided through active participation.
Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation.In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through).
With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain).Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person.This activity must be delivered in the second evaluation.

Pain neuroscience Education A pain neuroscience education session geared towards fear-avoidance beliefs
No Intervention: Control no intervention

Outcome Measures
Primary Outcome Measure: 1. Changes in Fear avoidance beliefs The Fear Avoidance Beliefs Questionnaire consists of two subscales: (1) a 7-item work subscale (FABQ-W) and (2) a 4-item physical activity subscale (FABQ-P).Both subscales score on a Likert-type scale from 0 to 6 points on each item.Higher scores indicate higher levels of fear-avoidance beliefs.
[Time Frame: baseline, 1-week post-intervention, and 4 -weeks post-intervention] 2. changes in pressure pain sensitivity An algometer will be used to measure pressure pain sensitivity (SPD), which is defined as the amount of applied pressure required for a subject to report the onset of pain sensation.It will be applied three times for each moment of evaluation and the average of the three applications will be considered.The unit of measure kg/cm2/s will be used.